Wyndham Condado Plaza Hotel & Casino • San Juan, Puerto Rico • January 24, 2004
The Marketing and Advertising Experience
Carmen Díaz Zayas is a faculty member and alumna of the Graduate Program in Translation at the University of Puerto Rico, from which she received a post-graduate certificate in Medical Translation. Her teaching experience includes general courses as well as specialty courses in medical, business, and environmental translation. In 1985, she co-founded Atabex Translation Specialists, Inc., a translation agency in Puerto Rico. Since its creation, the agency has offered general translation and interpreting services to private and government organizations in both Puerto Rico and the U.S.
Rafaela Mena is the director of the Drug Information Center of the School of Pharmacy, University of Puerto Rico (UPR), and is also a freelance medical translator. She graduated from the School of Pharmacy, UPR, in 1975 and from the Graduate Program in Translation, UPR, in 2000. She is presently a faculty member of the Food and Drug Administration/University of Puerto Rico joint venture for training the pharmaceutical manufacturing industry in current Good Manufacturing Practices. She also writes for the Puerto Rico Pharmacists Association quarterly publication and translates for the pharmacy journal The Annals of Pharmacotherapy.
Medical vis-à-vis Industrial Environment (Do You Speak Standard Operating Procedures?)
This panel presentation
offers a unique opportunity to step into the hands-on, highly regulated
world of pharmaceutical manufacturing operations and its documentation
requirements. A panel composed of experienced medical and in-house technical
translators will address the challenges and intricacies that translators
face when working with controlled documents, technical language, and production
line argot, as well as interacting with direct end-users and corporate
management. Actual members of the Amgen Opus Translation Team, one of
the most ambitious translation projects to take place within the pharmaceutical
industry, will share their expertise and translation techniques when translating
controlled and regulated documentation, including standard operation procedures,
batch records, and master formula plans.
José Rodríguez is a translator and document management services coordinator for Amgen LLC in Juncos, Puerto Rico. From the processing and translation of official and controlled documents, including standard operating procedures, manufacturing procedures, validations, and technical reports, to supporting the preparation of manuals, such as Writing Controlled Documents (Spanish), Writing Effective SOPs (English) and Writing Effective Manufacturing Procedures (English), he has been able to provide a unique conduit for the arduous task of developing bilingual technical glossaries and in-house communication guidelines in a highly regulated environment. His background as a consultant for the Department of Public Health, medical information systems specialist, business consultant, and volunteer community leader has earned him numerous awards and recognitions. He is also the translator of several books, including Aquí me quad, Puerto Ricans in Connecticut that was named one of the “ten books that moved Puerto Rico in 1997.” (Carmen Dolores Hernández, Sunday, December 28, 1997, El Nuevo Día). He has received an MA in Social Work from the University of Connecticut (West Hartford, Connecticut) and a BA in Art History from the University of New Haven (West Haven, Connecticut).
The Inside Story: Good Documentation Practices, Training and Development, Regulatory Affairs, and Compliance
What are Good Documentation Practices? Why is the Code of Federal Regulations, Subparts 210 and 211, so often quoted in controlled documents? What is the Food and Drug Administration’s role concerning pharmaceutical processes? What are the psychological considerations to be followed when translating for a highly skilled bi-cultural and bi-lingual work force? A panel of documentation and compliance specialists, as well as an in-house industrial psychologist, will address cultural diversity, register, localization, and regulatory and compliance issues. The session will explore special case studies and demonstrate practical exercises.
Paul B. Conlon, president of PBC Consulting, LLC, is an independent compliance consultant specializing in pharmaceutical and medical device Good Manufacturing Practices (GMP) compliance issues. He has over 25 years of diversified and progressive experience in manufacturing, packaging, validation, training, and quality assurance and is currently working on a long-term client assignment in Puerto Rico, assisting a major pharmaceutical company in developing, implementing, and managing corrective actions required in accordance with an existing consent decree with the Food and Drug Administration. His major client projects include Alpha Therapeutics Corporation, Aventis Behring, Bayer Corporation, Bioport, Eli Lilly and Company, Johnson and Johnson, Medtronic, Merck & Co., and SmithKline Beecham. He has received a BA in Business Administration and Management from Pace University (White Plains, New York) and holds various certifications including First-Line Management from the University of Connecticut, Good Manufacturing Practices from the Center for Professional Advancement, Pharmaceutical Quality Assurance from the New Jersey Pharmaceutical Quality Control Association, and Internal Auditing to the ISO 9000/Q90 Standards from the Quality Alert Institute.
PhD, is an experienced professional with an extensive background in management
development and training. Having created more than 25 training and orientation
programs for manufacturing personnel, he can achieve the delicate balance
between the technical requirements demanded by the pharmaceutical industry
and the correct usage of Spanish as the primary language. Recently retired
from Pfizer Pharmaceuticals, LLC (Barceloneta, Puerto Rico) where he held
the position of development director for 16 years, he now combines his
teaching and dissertation activities with the University of Minnesota,
University of Phoenix, Universidad Interamericana de Puerto Rico, and
the Pontificia Universidad Católica de Puerto Rico. As a professor
involved in graduate and undergraduate business administration programs,
he is presently researching the key language terms (English<>Spanish)
used in these programs, a study that he hopes will become an important
reference source for students, professors, and translators at the local
and international level.